Beschreibung
Senior Clinical Trial ScientistLocation: Allschwil
Start Date: ASAP
Duration: 12 months
Tasks:
- Core member of the clinical trial team (CTT)
- Collaborate closely with the Clinical Trial Physician (CTP) on relevant trial-related activities
- Develop a sound understanding of the science and medicine related to an indication and trial and perform literature searches as needed to keep knowledge up to date
- Main deliverables include the clinical trial protocol and related documents such as the ICF, study committee charters, study guidelines/instructions, PD code list, subject narratives, and the CSR
- Provide input into and review cross-functional trial documents such as the SAP, ESP requirements and specifications, monitoring guidelines, data review manual
- Perform data review and medical monitoring during the conduct of the trial
- Coordinate/manage the study committees
- Provide scientific input into responses for IRBs/ECs and Has
- Participate in discussions with external experts
- Train the relevant functions and roles on the scientific aspects of the trial
- Contribute to cross-functional and clinical development initiatives and processes as needed
Requirements
- PhD, Pharm D, MSc or equivalent university degree in life or health sciences
- At least 5 years of working experience in clinical development, in a contract research organization (CRO) or pharmaceutical company
- Experience in writing clinical study protocols, ICFs, scientific trial-related documents e.g., study committee charters
- Experience/Knowledge in the filed of kidney diseases and/or autoimmune diseases is desirable
- Solid experience in planning, set-up, conduct, closing, and reporting of phase II and III clinical studies from a scientific perspective
- Previous scientific contribution to cross-functional trial documents (e.g., SAP) guidelines, CRFs
- Solid experience with data review/medical monitoring
- Previous contributions to scientific discussions with external experts
- Good understanding of cross-functional clinical trial team roles, responsibilities, processes, and deliverables
- Good understanding of the drug development process, trial-related regulatory requirements/ICH GCP guidelines
- Fluent in English (written and oral)
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.